Application number that medical device manufacturers must file, to notify FDA of their intent to market a medical device at least 90 days in advance. Also known as Premarket Notification – PMN. This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, … Read more


Japanese method for workplace organization. The five S’s are seiri, seiton, seiso, seiketsu, and shitsuke or sorting, straightening, shining, standardizing, and sustaining. The picture shows a 5s organized tool system. Every tool has it’s place and if it is not there it is obvious.      


An acid is a solution with a pH <7. The pH of Lemon juice is around 2.


Active Pharmaceutical Ingredient


Annual Product Review


Acceptance Quality Level (Limit)


A base is also known as an alkali. A solution with a pH >7. Bleach has a pH around 12.

Batch Record

A controlled document that contains validated instructions on how to perform and document the manufacture of a product.


Can also be referenced as Microbial Limit Testing. Most often it is referring to the number of bacteria living on a surface or in a substance.     Photo Credit

Biotech Resume

This is a very good template for how to format your biotech resume. Highlight any skills you have that apply to the job you want. This example works for students and people interested in beginning a career in the biotechnology manufacturing industry.